{"id":11820,"date":"2021-09-07T08:45:06","date_gmt":"2021-09-07T06:45:06","guid":{"rendered":"https:\/\/www.agilelabs.co.za\/?page_id=11820"},"modified":"2021-09-07T08:45:36","modified_gmt":"2021-09-07T06:45:36","slug":"software-validation-testing","status":"publish","type":"page","link":"https:\/\/www.agilelabs.co.za\/fr\/software-validation-testing\/","title":{"rendered":"Validation et test du logiciel"},"content":{"rendered":"<p>Assurez la conformit\u00e9 \u00e0 votre emplacement<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Planification, test et gestion de la validation<\/h4>\n\n\n\n<p>Nous sommes des experts en conformit\u00e9 logicielle. Toutes les versions du logiciel ProCalV5 sont test\u00e9es et valid\u00e9es en interne avant leur publication. Des protocoles IQ\/OQ\/PQ peuvent \u00eatre fournis. Les plans de projet de validation de niveau GAMP 5, tous les documents n\u00e9cessaires et tous les services n\u00e9cessaires sont disponibles pour garantir une utilisation conforme sur vos sites. Les d\u00e9ploiements typiques prennent g\u00e9n\u00e9ralement moins de huit semaines.<\/p>\n\n\n\n<p><strong>Les services de planification, de test et de gestion de la validation peuvent inclure\u00a0:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>VMP (Validation du Sch\u00e9ma Directeur)<\/li><li>D\u00e9finir les attentes de validation, de nombreux efforts SDLC (System Development Life Cycle) d\u00e9pendent du VMP pour l&#039;autorisation et la direction<\/li><li>L&#039;\u00e9valuation des risques<\/li><li>Rationnel pour la hi\u00e9rarchisation des tests des exigences<\/li><li>Plan de test<\/li><li>D\u00e9finir les attentes de test t\u00f4t afin que le d\u00e9veloppement de scripts puisse \u00eatre d\u00e9marr\u00e9 avec un objectif clair, en \u00e9vitant les erreurs de direction et les faux d\u00e9parts<\/li><li>Script<\/li><li>Ressourcement<\/li><li>Prise en charge de l&#039;ex\u00e9cution des tests<\/li><li>R\u00e9solution d&#039;\u00e9cart<\/li><li>VSR (Rapport r\u00e9capitulatif de validation)<\/li><li>R\u00e9sumer les tests, les \u00e9carts, les r\u00e9solutions et les exceptions bas\u00e9es sur les risques<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Aper\u00e7u QSR et GMP pour les programmes d&#039;\u00e9talonnage<\/h4>\n\n\n\n<p>Lors de la mise en \u0153uvre d&#039;un nouveau programme d&#039;\u00e9talonnage dans vos op\u00e9rations commerciales, les pratiques de qualit\u00e9 et de conformit\u00e9 doivent \u00eatre prises en compte ainsi que les pratiques de fabrication. Les questions ci-dessous peuvent vous aider \u00e0 organiser vos objectifs.<\/p>\n\n\n\n<p><strong>Termes:<\/strong><br>BPF = Bonnes Pratiques de Fabrication<br>QSR = R\u00e9glementation du Syst\u00e8me Qualit\u00e9<\/p>\n\n\n\n<p><strong>Pourquoi l&#039;\u00e9talonnage des \u00e9quipements fait-il partie des BPF\/QSR\u00a0?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Un fabricant doit d\u00e9velopper et mettre en \u0153uvre un syst\u00e8me de qualit\u00e9 qui garantit que tous les produits finis r\u00e9pondent aux sp\u00e9cifications du dossier principal des appareils\/m\u00e9dicaments de l&#039;entreprise.<\/li><li>L&#039;assurance est obtenue de plusieurs mani\u00e8res, y compris la mesure des param\u00e8tres des composants, des produits et des processus pendant la conception et la production.<\/li><\/ul>\n\n\n\n<p><strong>Quelles sont les responsabilit\u00e9s du fabricant ?<\/strong><\/p>\n\n\n\n<p>Pour s&#039;assurer que tous les \u00e9quipements de production et de test d&#039;AQ, y compris les \u00e9quipements m\u00e9caniques, \u00e9lectroniques, automatis\u00e9s et chimiques sont\u00a0:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Convient \u00e0 l&#039;utilisation pr\u00e9vue<\/li><li>Capable de produire des r\u00e9sultats valides<\/li><li>Exploit\u00e9 par des employ\u00e9s form\u00e9s<\/li><li>Correctement calibr\u00e9 par rapport \u00e0 un \u00e9talon appropri\u00e9<\/li><\/ul>\n\n\n\n<p><strong>Qu&#039;est-ce qui est inclus dans les proc\u00e9dures?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Objet et port\u00e9e<\/li><li>Fr\u00e9quence d&#039;\u00e9talonnage<\/li><li>\u00c9quipement et normes requis<\/li><li>Limites d&#039;exactitude, de pr\u00e9cision et de biais<\/li><li>Une description du processus d&#039;\u00e9talonnage<\/li><li>Des mesures correctives<\/li><li>Exigences en mati\u00e8re de documentation<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Objectif et port\u00e9e<\/h4>\n\n\n\n<p>L&#039;assurance qualit\u00e9 doit d\u00e9terminer quelles mesures sont n\u00e9cessaires pour s&#039;assurer que la conception des dispositifs\/m\u00e9dicaments et les param\u00e8tres de processus sont conformes aux sp\u00e9cifications \u00e9tablies en mati\u00e8re d&#039;exactitude, de pr\u00e9cision et de biais.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Fr\u00e9quence d&#039;\u00e9talonnage<\/h4>\n\n\n\n<p>D\u00e9pend du type d&#039;\u00e9quipement, de la fr\u00e9quence d&#039;utilisation et de sa criticit\u00e9 dans le processus de fabrication. Autres facteurs pouvant affecter le fonctionnement de l&#039;\u00e9quipement\u00a0:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Temp\u00e9rature<\/li><li>Humidit\u00e9<\/li><li>Contamination<\/li><li>\u00c9lectricit\u00e9 statique<\/li><li>Champs magn\u00e9tiques<\/li><li>Fluctuations de l&#039;alimentation<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u00c9quipement et normes<\/h4>\n\n\n\n<p>Tous les \u00e9quipements et normes utilis\u00e9s doivent \u00eatre d\u00e9crits en d\u00e9tail dans le fichier principal du dispositif\/m\u00e9dicament ou dans les enregistrements du syst\u00e8me qualit\u00e9. Les caract\u00e9ristiques environnementales telles que la temp\u00e9rature, l&#039;humidit\u00e9, les vibrations et la propret\u00e9 doivent \u00eatre prises en compte lors de l&#039;\u00e9talonnage et de l&#039;utilisation de l&#039;\u00e9quipement.<\/p>\n\n\n\n<p><strong>\u00c9quipement<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Qualification d&#039;installation (QI)\u00a0: mesure prise pour garantir que l&#039;\u00e9quipement et les syst\u00e8mes auxiliaires sont correctement install\u00e9s, r\u00e9pondent aux sp\u00e9cifications et aux intentions de conception des fabricants, fonctionnent correctement dans la plage d&#039;utilisation pr\u00e9vue<\/li><li>Qualification op\u00e9rationnelle (QO)\u00a0: action entreprise pour garantir que l&#039;\u00e9quipement et les sous-syst\u00e8mes sont capables de fonctionner de mani\u00e8re coh\u00e9rente dans les limites et les tol\u00e9rances \u00e9tablies<\/li><li>Qualification des performances (QP)\u00a0: action entreprise pour s&#039;assurer que l&#039;\u00e9quipement d&#039;un syst\u00e8me fonctionne de mani\u00e8re efficace et constante dans le temps<\/li><\/ul>\n\n\n\n<p><strong>\u00c9quipement et normes<\/strong><\/p>\n\n\n\n<p>Dans la mesure du possible, les normes doivent \u00eatre tra\u00e7ables jusqu&#039;\u00e0 l&#039;Institut national des normes et<br>technologie (NIST).<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Les \u00e9talons priv\u00e9s sont envoy\u00e9s au NIST pour \u00e9talonnage et renvoy\u00e9s<\/li><li>Le NIST fournit des mat\u00e9riaux de r\u00e9f\u00e9rence standard \u00e0 utiliser dans le programme d&#039;\u00e9talonnage<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Limites d&#039;exactitude, de pr\u00e9cision et de biais<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>&nbsp;Pr\u00e9cision : la mesure de la capacit\u00e9 d&#039;un instrument \u00e0 obtenir la valeur vraie ou absolue<\/li><li>Pr\u00e9cision : indique le degr\u00e9 relatif de r\u00e9p\u00e9tabilit\u00e9<\/li><li>Biais\u00a0: une mesure de la proximit\u00e9 de la valeur moyenne dans une s\u00e9rie de mesures se rapproche de la vraie valeur<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Des mesures correctives<\/h4>\n\n\n\n<p>A lieu lorsque les limites ne sont pas respect\u00e9es. Les mesures correctives devraient inclure les dispositions suivantes\u00a0:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>D\u00e9crire et initier toute action requise pour r\u00e9tablir ces limites (r\u00e9\u00e9talonnage)<\/li><li>\u00c9valuer s&#039;il y a eu un effet ind\u00e9sirable sur le dispositif\/la qualit\u00e9 du m\u00e9dicament<\/li><li>Documenter toutes les mesures prises et les \u00e9valuations men\u00e9es<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Exigences en mati\u00e8re de documentation<\/h4>\n\n\n\n<p>Syst\u00e8me papier ou logiciel :<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Identification de l&#039;\u00e9quipement (y compris le num\u00e9ro de mod\u00e8le)<\/li><li>Num\u00e9ro de s\u00e9rie<\/li><li>Date d&#039;\u00e9talonnage<\/li><li>Nom du calibrateur<\/li><li>Date du prochain \u00e9talonnage<\/li><li>Sp\u00e9cifications d&#039;\u00e9talonnage<\/li><li>Adresse du fabricant (facultatif)<\/li><li>Raison de l&#039;\u00e9talonnage (facultatif)<\/li><li>Commentaires (optionnel)<\/li><li>Informations sur le service ext\u00e9rieur (facultatif)<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Personnel d&#039;\u00e9talonnage<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>Doit \u00eatre suffisamment form\u00e9 par l&#039;\u00e9ducation et\/ou l&#039;exp\u00e9rience pour effectuer des \u00e9talonnages.<\/li><li>Doit avoir une connaissance de base des concepts de m\u00e9trologie et d&#039;\u00e9talonnage<\/li><li>Avoir une compr\u00e9hension des principes de base des disciplines de mesure, des \u00e9tapes de traitement et des exigences d&#039;acceptation<\/li><li>Connaissance du programme d&#039;\u00e9talonnage global<\/li><li>Capacit\u00e9 \u00e0 suivre les instructions concernant l&#039;entretien et l&#039;utilisation de l&#039;\u00e9quipement<\/li><li>Attitude consciencieuse<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Confirmation de la conformit\u00e9<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>Audit du programme d&#039;\u00e9talonnage<\/li><li>Audits internes (requis par QSR)<\/li><li>Maintenir un horaire adapt\u00e9<\/li><li>Maintenir une documentation appropri\u00e9e<\/li><li>Maintien appropri\u00e9 des normes<\/li><li>Ad\u00e9quation des mesures correctives<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Audits externes<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>La FDA consid\u00e8re les laboratoires sous contrat comme une extension du programme BPF d&#039;un fabricant, de sorte que les p\u00e9riodiques sont appropri\u00e9s<\/li><li>Obtenir la documentation v\u00e9rifiant que l&#039;\u00e9quipement a \u00e9t\u00e9 \u00e9talonn\u00e9 dans des conditions contr\u00f4l\u00e9es \u00e0 l&#039;aide d&#039;\u00e9talons tra\u00e7ables<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Pr\u00e9occupations suppl\u00e9mentaires<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>L&#039;\u00e9quipement de fabrication utilis\u00e9 dans le processus de production (s&#039;il est automatis\u00e9) doit \u00eatre p\u00e9riodiquement calibr\u00e9<\/li><li>L&#039;\u00e9quipement de fabrication contr\u00f4l\u00e9 par ordinateur doit \u00eatre valid\u00e9 pour son utilisation pr\u00e9vue et \u00eatre inclus dans un programme d&#039;\u00e9talonnage<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Addendum de d\u00e9finitions<\/h4>\n\n\n\n<p><strong>Qualification d&#039;installation (QI)\u00a0:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Avez-vous obtenu ce que vous vouliez?<\/li><li>Disposez-vous des installations ad\u00e9quates pour l&#039;utiliser?<\/li><li>Est-ce que tous les \u00e9quipements sont correctement comptabilis\u00e9s :<ul><li>Num\u00e9ro de s\u00e9rie<\/li><li>Fabricant<\/li><li>Num\u00e9ro d&#039;actif interne<\/li><li>Installation correcte<\/li><li>Carnet d&#039;instruments en place<\/li><li>Emplacement du laboratoire<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>Qualification op\u00e9rationnelle (QO)\u00a0:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Documentation qui v\u00e9rifie que l&#039;\u00e9quipement de laboratoire fonctionne dans les plages d&#039;utilisation pr\u00e9vues<\/li><li>S\u00e9rie de tests fonctionnels pour s&#039;assurer qu&#039;un instrument\/syst\u00e8me fonctionne conform\u00e9ment aux limites d&#039;un ensemble pr\u00e9d\u00e9termin\u00e9 de crit\u00e8res<\/li><\/ul>\n\n\n\n<p><strong>Qualification des performances (QP)\u00a0:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Indique qu&#039;un ensemble sp\u00e9cifique de param\u00e8tres de m\u00e9thode fonctionne correctement par rapport \u00e0 la validation de la m\u00e9thode historique<\/li><li>Dans certains cas, l&#039;ad\u00e9quation du syst\u00e8me peut \u00eatre acceptable comme qualification de performance<br>Requalification (RQ)\u00a0:<\/li><li>D\u00e9termination qu&#039;un instrument, apr\u00e8s r\u00e9paration, service du fournisseur, changement d&#039;emplacement ou ajustements ont \u00e9t\u00e9 effectu\u00e9s, fonctionne comme pr\u00e9vu et pr\u00e9vu<\/li><li>Consid\u00e9rations<ul><li>L&#039;instrument r\u00e9pond-il aux protocoles originaux \u00e9tablis ?<\/li><li>Si non, quelles d\u00e9cisions doivent \u00eatre prises ?<\/li><\/ul><\/li><\/ul>","protected":false},"excerpt":{"rendered":"<p>Ensure Compliance At Your Location Validation Planning, Testing And Management We are software compliance experts. All versions of ProCalV5 software are internally tested and validated before release. IQ\/OQ\/PQ protocols can be provided. GAMP 5 level validation project plans, all necessary documents and any needed services are available to ensure compliant use at your locations. Typical<\/p>\n<p class=\"more-link\"><a href=\"https:\/\/www.agilelabs.co.za\/fr\/software-validation-testing\/\" class=\"themebutton\">Lire la suite<\/a><\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[],"tags":[],"class_list":["post-11820","page","type-page","status-publish","hentry"],"acf":[],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO Pro 4.7.0 - aioseo.com -->\n\t\t<meta name=\"description\" content=\"Ensure Compliance At Your Location Validation Planning, Testing And Management We are software compliance experts. All versions of ProCalV5 software are internally tested and validated before release. IQ\/OQ\/PQ protocols can be provided. 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